Extracorporeal devices and methods for facilitating cessation of undesired behaviors

ABSTRACT

Devices, Methods and Systems are disclosed for assisting patients in behavioral modification and cessation programs aimed at terminating undesired behaviors such as smoking, alcohol use and others. Patient devices with automated patient prompting for self-testing, analysis of test results and data logging are included in a networked system with a specifically designed treatment modality.

RELATED APPLICATION DATA

This application claims the benefit of priority of U.S. ProvisionalPatent Application Ser. No. 61/254,685, filed Oct. 24, 2009, and titledExtracorporeal Devices and Method for Intermittent Signaling andPrompting of Patient Self-Testing for Substances, which is incorporatedby reference herein in its entirety.

FIELD OF THE INVENTION

The present invention generally relates to the field of behavioralmodification. In particular, exemplary embodiments of the presentinvention are directed to extracorporeal devices, systems and methodsfor facilitating cessation of undesired behaviors.

BACKGROUND

Certain persons may engage in certain undesirable activities that havesignificant negative acute and/or long-term health, social, and safetyimplications for the person and for other associated persons. In somecases, the person may wish to quit this behavior. Often, the person'sfamily, friends, and/or healthcare providers are also engaging with theperson in an attempt to have them quit the behavior. Associated personsmay also be negatively impacted by the behavior, socially, financially,and from a health perspective. Such behavioral modification or cessationattempts to terminate the undesirable behavior may be formal andadministered by healthcare professionals, or the person may take theirown personalized approach to cessation.

An example of such a behavioral modification program is a formalmulti-modality smoking cessation program that utilizes counseling anddrug therapy to achieve the end goal of abstinence from smoking. Drugtherapy typically includes one or more of: nicotine replacement therapy,welbutryn, varenicline, and other drugs. Alcohol cessation programs, bycomparison, may include similar approaches with counseling and druginterventions targeted specifically to achieve abstinence from alcoholuse and abuse.

In a typical multi-modality smoking cessation program, participants areasked to voluntarily and honestly report on their smoking behaviorbefore and during therapy. For example, the patient's baseline smokingbehavior is measured according to the patient's own voluntary report andis based solely on their recall (i.e., patient states that they averageforty cigarettes per day prior to entering program). The patient mayalso be asked to provide a blood sample at the clinic or hospitallocation to test for substances associated with smoking behavior, suchas hemoglobin bound to carbon monoxide. Alternatively, the patient maybe asked to exhale into a device at the clinic or hospital location todetect carbon monoxide levels in the exhaled gas from the lungs. Suchtests would be performed on location and observed by the health careprovider, and such tests may require processing by a professionallaboratory. Based on the values of carbon monoxide or other substancesat this specific point in time, a gross estimate of smoking behavior maybe made by the health care professional. Limitations of such testing arethat it is made at a single point in time and likely does not fully andaccurately reflect the true behavior of the patient at multiple timepoints before entering the program. The patient may alter theirbehavior, for example, for days prior to testing thus making the testresult less relevant and accurate.

At each visit during a patient's cessation program participation, thepatient's interval smoking behavior since the previous visit isquantified by patient voluntary reporting (recollection, diary, etc.).For example, if the patient is seen weekly, they will report on theirsmoking behavior for the prior seven days. Typically, the patient keepsa diary or smoking log during each interval in which daily entries aremade regarding the number of cigarettes smoked and certain lifestyleevents that occur in conjunction with smoking behavior. This methodologyrelies on compliance and full disclosure by the smoker, as well as acommitment to record the data every day.

Clinical trials have shown that patients often fail to disclose theirtrue smoking behavior when queried in this manner, grosslyunder-reporting the amount of smoking that takes place or forgettingcertain lifestyle events that are associated with smoking. Theselimitations in reporting impair the effectiveness of the program.Further, blood tests or exhaled carbon monoxide breath tests may beperformed on the spot at these weekly or biweekly visits, to detectsubstances associated with smoking. Unfortunately, such predictable andinfrequent testing gives the patient the opportunity to abstain forhours or longer prior to the visit to avoid detection of smokingbehavior or to lessen the positivity of the test. Such behavior resultsin collecting physiological data that erroneously suggests that smokinghas stopped or diminished. For example, if a patient has a bi-weekly 3pm clinic visit on Mondays, they may abstain from smoking after 9 am onthe day of the visit so that their blood and exhaled breath levels ofcarbon monoxide decline or normalize in time for the test. Further, suchspot testing by the clinic is infrequent and does not accuratelyrepresent patient behavior during non-clinic days. Due to thesesignificant limitations, counseling and drug therapy cannot beaccurately and effectively tailored to optimize patient outcomes. Ifhealthcare professionals do not have accurate information regarding truepatient behavior, for example, the efficacy of the cessation programwill be severely impaired. This is one reason why failures of smokingcessation programs, as well as other behavioral cessation programs, areso high and recidivism almost guaranteed. Given the currently limitedoptions for objectively determining a patient's smoking behavior, (orother behaviors) a more objective and accurate means of determining apatient's behavior is needed.

SUMMARY OF THE DISCLOSURE

In one exemplary embodiment of the present invention, a method forfacilitating cessation of undesired behavior in a patient includes stepssuch as configuring a patient device with a predetermined test protocolincluding patient test prompts, prompting the patient in accordance withthe predetermined test protocol to provide at least one biological inputto the patient device, the biological input being correlated to theundesired behavior, analyzing the patient biological input to thepatient device, generating a machine readable data set representative ofthe patient input based on the analyzing, associating the data set witha specific patient biological input, evaluating the predetermined testprotocol based on the data set, and altering or maintaining thepredetermined test protocol based on the evaluation. In certainembodiments, such a method may also include steps of determining whetherthe patient properly provided a biological input in response to theprompting, and re-prompting the patient to provide the at least onebiological input when the determining result is negative.

Other aspects of exemplary embodiments may include remotelyreconfiguring the test protocol in the patient device through acommunications network, prompting the patient to input requestedinformation to the patient device through a user interface, andassociating the requested information with the data set associated witha specific patient's biological input. Additionally, the evaluating maybe based on the requested information associated with the data set.

In further exemplary embodiments, methods according to the presentinvention may include transmitting the data set and associated requestedinformation to a health care provider device. Other optional steps mayinclude communicating with the patient device through a network, andprompting the patient to provide at least one biological input outsideof the predetermined test protocol. In order to arrive at a testprotocol, exemplary embodiments may also include collecting data relatedto the patient undesired behavior, and analyzing the patient behaviordata to determine the predetermined test protocol.

In another exemplary embodiment of the present invention, system forfacilitating cessation of undesired behavior in a patient includes apatient device or PD and a health care provider device or HCPD that areconfigured to communicate with one another through a network or otherknown means of data transfer. The PD may be configured and dimensionedto be carried by the patient, may include a PD user interface, a testelement configured to receive a biological input from the patient andoutput information representative of the content of the biologicalinput, a PD storage module containing instructions for various functionsincluding for a predetermined test protocol, and a PD execution modulecommunicating with the user interface, the test element and the storagemodule, the PD execution module configured to execute instructionscontained in said PD storage module.

The predetermined test protocol instructions may, for example, includeprompting the patient through the user interface to provide a biologicalinput to the test element at selected intervals, determining thecompleteness of a biological input, and providing additional patientprompts based on the completeness determination.

In such exemplary embodiments, an HCPD may be configured to be accessedby a health care provider, and include an HCPD user interface, an HCPDstorage module containing certain instructions and an HCPD executionmodule communicating with the user interface and storage module, theexecution module configured to execute instructions contained in theHCPD storage module.

Instructions stored in the HCPD storage module may include instructionsfor displaying and manipulating information representative of thecontent of the biological input, and revising the predetermined testprotocol based on at least one of user input and the informationrepresentative of the content of the biological input.

In certain other exemplary embodiments instructions for executing somefunctions may be stored in either the PD or HCPD storage modules andexecuted by the associated execution modules as appropriate. Examples ofsuch instructions may include instructions for generating a machinereadable data set based on the test element output information, and forassociating the data set with a specific patient biological input, orinstructions for causing the patient device to prompt the patient toinput requested information to the patient device through the PD userinput and for associating the requested information with a data setassociated with a specific patient biological input.

In further exemplary embodiments, the patient device may further includean identification device for acquiring patient identifying informationcorrelated to a biological input. Such an identification device maycommunicate with the storage module and execution module for associatingthe acquired identifying information with the correlated biologicalinput and storing the associated identifying information. The system mayalso permit receiving unprompted patient input through the PD user inputand then associating the unprompted input with a biological input basedon a predetermined algorithm.

In another exemplary embodiment of the present invention, an apparatusfor use in connection with facilitating cessation of undesired behaviorin a patient, may include at least one housing configured anddimensioned to be carried by the patient, a user interface disposed inthe at least one housing, a test element disposed in the at least onehousing, the test element being configured to receive a biological inputfrom the patient and output information representative of the content ofthe biological input, a storage module containing instructions relatedto the operation of the apparatus, and an execution module communicatingwith the user interface, the test element and the storage module.

Exemplary instructions contained in the storage model, which may beexecuted by the execution module, may include instructions for executinga predetermined test protocol, b) generating user readable indicatorbased on the test element output and displaying the output on the userinterface, associating the user readable indicator with a specificbiological input, associating the requested information with a specificuser readable indicator associated with a specific patient biologicalinput, and storing test result information including the user readableindicator and associated requested information in the storage module.The predetermined test protocol instructions may include steps ofprompting the patient through the user interface to provide a biologicalinput to the test element at selected intervals, determining thecompleteness of a biological input, providing additional patientbiological input prompts based on the completeness determination, andprompting the patient to input requested information through the userinterface.

In some exemplary embodiments, the apparatus may be configured tocommunicate through a network for transfer of the test resultinformation.

In yet another exemplary embodiment of the present invention, a methodfor collecting and confirming patient participation in select behaviors,may include steps such as configuring a patient device with apredetermined test protocol including patient test prompts, promptingthe patient in accordance with the predetermined test protocol toprovide at least one biological input to the patient device, thebiological input being correlated to the select behavior, determiningwhether the patient properly provided a biological input in response tothe prompting, re-prompting the patient to provide the at least onebiological input when the determining result is negative, analyzing thepatient biological input to the patient device, generating a machinereadable data set representative of the patient input based on theanalyzing, associating the data set with a specific patient biologicalinput, prompting the patient to input requested information to thepatient device through a user interface, associating the requestedinformation with the data set associated with a specific patientbiological input, evaluating the predetermined test protocol based onthe data set and the requested information associated with the data set.

BRIEF DESCRIPTION OF THE DRAWINGS

For the purpose of illustrating the invention, the drawings show aspectsof one or more embodiments of the invention. However, it should beunderstood that the present invention is not limited to the precisearrangements and instrumentalities shown in the drawings, wherein:

FIG. 1 is a block diagram illustrating a patient monitoring deviceaccording to an exemplary embodiment of the present invention.

FIG. 2 is a diagram illustrating a system according to an exemplaryembodiment of the present invention.

FIG. 3 is a flow chart illustrating a method according to an exemplaryembodiment of the present invention.

DETAILED DESCRIPTION

Embodiments of the present invention provide devices, methods andsystems capable of prompting a patient to perform self-testing forundesired behaviors, objectively analyzing the test results, logging thedata to a local or central storage unit, and providing a comprehensiveinterface for the patient and healthcare professional to analyze andobserve results and correlate these results with progress within acessation program. Such self-testing may be according to a protocol thatis monitored and altered in real time to adapt to specific circumstancesof the patient's needs. While exemplary embodiments of the presentinvention are described in more detail in connection with smokingcessation, and to some extent alcohol cessation, it will be appreciatedby those skilled in the art that the devices, methods and systems taughtherein are generally applicable to facilitating behavior modificationwith respect to any number of undesired behaviors for which markers arepresent in the patient's breath or saliva.

A number of undesirable behaviors that involve smoking of one or moresubstances, oral ingestion of one or more substances, oral placement ofone or more substances, transdermal absorption of one or moresubstances, nasal sniffing of one or more substances, and other methodsof absorbing one or more substances result in the subsequent presence ofone or more of the substances in the exhaled breath. The presence of aunique substance or substances in the exhaled breath can be used as amarker for the specific undesirable behavior and intermittent testing ofthe exhaled breath for this substance(s) can quantify the occurrence ofthe undesirable behavior.

Such substances may be detected in the exhaled breath due to one or moreof the following mechanisms: 1) the substance was previously absorbedinto the body and bloodstream and is then released from the bloodstreaminto the pulmonary airspace for exhalation, 2) the substance was veryrecently inhaled into the pulmonary dead space (non-absorbing portion ofinhaled air) and is being exhaled acutely therefore not requiring ablood level of the substance to be present, 3) the substance is presentin the oral cavity mucous and epithelial surface layers and certainportions volatilized into the exhaled breath, 4) the substance waspreviously absorbed into the body and bloodstream and is then releasedfrom salivary glands into the oral cavity in the saliva and thenvolatilized into the exhaled breath, and/or 5) the substance was exhaledpreviously and a portion of the substance was retained within the oralcavity mucous and epithelial surface layers and certain portionssubsequently volatilized into the exhaled breath.

One alternative to intermittently testing the exhaled breath to detectone or more substances associated with an undesirable behavior is tointermittently test saliva for one or more substances associated with anundesirable behavior, as these substances as disclosed above oftenreside in the oral cavity via secretion within the saliva from thebloodstream or accumulation within the oral cavity mucous, saliva, andepithelial lining due to ingestion or exhalation residues.

In the specific example of smoking cessation, high quality objectivedata collected in an improved manner could be used by the healthcareprofessional to adjust therapy (i.e., nicotine replacement therapy,other drug therapy, counseling, etc.) to achieve a better outcome, toprovide real-time or delayed positive and negative feedback to thepatient, to determine success or failure of the cessation program, andto provide long-term maintenance of cessation after successfullyquitting the behavior (avoidance of recidivism). For example, if smokingbehavior remained unchanged after initiating counseling and a trial ofnicotine replacement therapy (NRT), the dose of the NRT could beimmediately increased and/or other therapies could be added with thisapproach. Likewise, as smoking behavior began to improve as evidenced byobjective signs of decreased frequency of smoking, the various therapiescould be titrated downward and ultimately discontinued.

An exemplary embodiment of a patient monitoring device according to thepresent invention is illustrated in FIG. 1. In this exemplaryembodiment, patient device 10 includes two main components:extra-corporeal detector unit 12 containing at least one test elementand signaling unit 16. The components may be combined into a single unitor may be separated physically. Other embodiments may include additionalcomponents and these components may be combined or separate as well.

Extra-corporeal detector unit 12 includes at least one test element thatis capable of detecting a substance in a biological input from thepatient that is indicative of recent targeted behavior. The detectoranalyzes the biological input from the patient, such as expired gas fromthe lungs or saliva, and in at least one embodiment logs the date andtime of day, quantifies the presence of the targeted substance(s), andthen stores the data for future analysis and/or sends the data to aremote location for analysis. Detector unit 12 thus may include aprocessor, memory and user interface 14 as appropriate for its specificfunctions. The user interface may include data inputs such as a touchscreen, keyboard or pointer.

Detector units may be specifically configured by person of ordinaryskill in the art for detection of specific marker substances related totargeted behaviors as described herein. Examples of substances detectedrelated to smoking include but are not limited to carbon monoxide,nitrogen oxides, ammonia, arsenic, nicotine, acetone, acetaldehyde,formaldehyde, hydrogen cyanide, isoprene, methyl ethyl ketone, benzene,toluene, phenol, and acrylonitrile. Sensor technologies for detectingalcohol in the exhaled breath include infrared spectrophotometertechnology, electrochemical fuel cell technology, or a combination ofthe two. Smaller portable units well suited for use in embodiments ofthe invention may be based on electrochemical fuel cell analysis or“Taguchi cell” sensors.

One example of a suitable detector unit for determining the presence ofalcohol in the breath is described in U.S. Pat. No. 7,797,982, entitled“Personal Breathalyzer Having Digital Circuitry.” Another example ofdetector units that may be configured to determine the presence of avariety of substances is disclosed in U.S. Pat. No. 7,421,882, entitled“Breath-based Sensors for Non-invasive Molecular Detection.” U.S. Pat.No. 7,525,093, entitled “Liquid or Gas Sensor and Method” disclosesanother sensor device that may be readily incorporated into embodimentsof the present invention by persons of ordinary skill in the art. Eachof the forgoing U.S. patents are incorporated by reference herein intheir entirety.

Detector unit 12 may also be configured to recognize a uniquecharacteristic of the patient, such as a fingerprint, retinal scan,voice label or other biometric identifier, in order to prevent, at leastto a degree, having a surrogate respond to the signaling and testprompts to defeat the system. For this purpose, patient identificationsub-unit 15 may be included in detector unit 12. Persons of ordinaryskill in the art may configure identification sub-unit 15 as needed toinclude one or more of a fingerprint scanner, retinal scanner, voiceanalyzer, or face recognition as are known in the art. Examples ofsuitable identification sub-units are disclosed, for example in U.S.Pat. No. 7,716,383, entitled “Flash-interfaced Fingerprint Sensor,” andU.S. Patent Application Publication No. 2007/0005988, entitled“Multimodal Authentication,” each of which is incorporated by referenceherein in their entirety.

Identification sub-unit 15 may also comprise a built in still or videocamera, which would record a picture or video of the patientautomatically as the biological input is provided to the test element.Regardless of the type of identification protocol used, the processorand memory in the detector unit will associate the identification withthe specific biological input, for example by time reference, and maystore that information along with other information regarding thatspecific biological input for later analysis.

A patient may also attempt to defeat the detector by blowing into thedetector with a pump, bladder, billows, or other device, for example,when testing exhaled breath. In the embodiment of saliva testing, apatient may attempt to substitute a “clean” liquid such as water. Whileno means will absolutely prevent an uncooperative and determined patientfrom these attempts, some means to defeat these attempts can beincorporated in to the system. For example, the detector unit mayincorporate the capability of discerning between real and simulatedbreath delivery. In one exemplary embodiment this functionality may beincorporated by configuring detector unit 12 to sense oxygen and carbondioxide, as well as the maker substance (carbon monoxide, etc.). In thismanner, the detector is able to confirm that the gas being analyzed istruly coming from expired breath, as expired breath has lower oxygen andmuch higher carbon dioxide than ambient air. In another embodiment, thedetector unit may be additionally configured to detect enzymes naturallyoccurring in saliva so as to distinguish between saliva and otherliquids. Basic biochemical tests are well known to persons skilled inthe art for identifying such substances.

Signaling unit 16 may communicate with detector unit 12 through anappropriate communication link 20 (for example, wired, WI-FI, Bluetooth,RF, or other means) as may be devised by a person of ordinary skill inthe art based on the particular application. Signaling unit 16 may beintegrated with detector unit 12 in patient device 10 or may separatefrom the detector unit, but the units are synchronized and able tocommunicate real-time or at various intervals in order to correlatesignaling and detector results. Thus, when physically separate fromdetector unit 12, signaling unit 16 may include its own processor,memory and graphical user interface 18, but when integrated withdetector unit 12 both units may share one of more of thosesubcomponents. Utilizing graphical user interface 18, signaling unit 16prompts the patient to blow into the detector unit at various times ofthe day, and/or prompts the patient to test their saliva or other bodyfluid as appropriate for the specific detector unit input. Together,memory for detector unit 12 and signaling unit 16 will containinstructions appropriate for operation of the patient device inaccordance with the various method embodiments described herein.

In some circumstances, a prompt to test may have to be ignored forreasons not considered noncompliant due to the patient being engaged inan activity that prevents testing, such as exercise, work, driving, etc.A means by which to delay testing in response to a prompt, such as“snooze button” 19 may be incorporated. For example, if a patient isdriving a vehicle, they may push button 19 to activate a preset intervaluntil the test is again requested. A certain number of delays may bepermitted each day, with this number being set by the provider orpatient in the program.

Signaling unit 16 may also include means permitting the patient to inputinformation that the patient believes relevant to his or her conditionwithout prompting. Such information may, for example, includeinformation about the patient's state of mind, that is feeling stressedor anxious. Such unprompted information could then be correlated to abiological input based on a predetermined algorithm, such as beingassociated with the biological input that is closest in time to theunprompted input, or associated with the first biological inputoccurring after the unprompted input.

In one exemplary embodiment of patient device 10, detector and signalingunits 12, 16 are combined and exist in an entirely portableconfiguration with battery power. Such embodiments may also be providedwith network connection capability (WI-FI, wireless cell, RF, etc.) asdescribed in greater detail below. For example, a PDA-like device thatis able to both signal the patient as well as perform the expired gasanalysis could be carried in the patient's pocket at all times andimprove compliance by the patient by allowing them to respondimmediately to notifications.

In yet another exemplary embodiment, wherein detector unit 12 andsignaling unit 16 are physically separate units, the signaling unit maybe configured to be worn as a wristwatch or carried like a PDA.Likewise, the detector would be worn or carried, but separately. In anyseparate unit embodiment, the units are time synchronized or linked viaa wireless communication link 20 to allow analysis of the time dependentdata (linking of the notification and exhalation events).

In the example of a combined unit or wirelessly (or wired) connectedunits, either the detector or the signaling unit could act as thestorage entity for the data utilizing its own internal memory.Alternatively, either could act as the sending unit to upload the datato a remote source for live tracking of patient data as described inmore detail below. Data could be uploaded immediately, intermittently ornot at all. The data could also be downloaded from the storage mediaeither by the patient or health care professional

In a further exemplary embodiment, as illustrated in FIG. 2, system 30includes mobile patient devices 10 (including integrated detector andsignaling units) and/or stand alone detector units 12 that communicatethrough network 32 with healthcare provider base station 34. Network 32may comprise the Internet, a land-based or cellular telephone network orany other communications networks or combination of networks asappropriate for the particular patients and cessation program.Healthcare provider base station 34 may comprise a specially programmedpersonal computer in a doctor's office linked to communication network32 through an appropriate communications buss or a specialized deviceincluding its own memory, processor and graphical user interface.Persons of ordinary skill in the art may configure and program basestation 34 based on the teachings contained herein.

System 30 also may include fixed patient devices 36. Fixed patientdevices may comprise substantially the same components as mobile patientdevices 10 except that they are configured to be fixed at a particularlocation such as a patient's home, office or automobile. In addition,system 30 permits remote programming by the healthcare provider asappropriate for the particular patient and/or cessation program. Anexemplary method for implantation of a cessation program utilizingsystem 30 is described in greater detail with reference to the flowchart of FIG. 3.

As illustrated in FIG. 3, system 30 may be preprogrammed to prompt thepatient at specific times (step 40) and/or the healthcare provider (HCP)may randomly prompt the patient (step 42) when there is a concern thatbehavior is timed to avoid preprogrammed prompts. Alternatively theprogrammed prompts 40 may occur at random intervals as described in moredetail below. For example, patient devices 10 may be programmed to beoperational during prescribed hours (typically waking hours, for examplefrom 6 am to 11 pm), although sleep hour function can be activated. Thepatient is prompted at various times throughout the day to exhale intothe detector. The patient is instructed (step 44) with each promptregarding how to properly and consistency perform the requested test. Inone example of an algorithm for breath testing, the patient will takeseveral full breaths in and out into the detector, followed by a deeptest exhalation for the detector to analyze. A determination is thenmade (step 46) as to whether the patient has complied. Circumstances ofnon-compliance may also be determined (step 48). For example if device10 determines that there was simply no attempt at compliance the patientmay be re-instructed a set number of times (branch 50). However, after apredetermined number of re-instructions without compliance, the devicesimply may report a non-compliant episode (branch 52). Alternatively, ifit is determined that the patient attempted to comply but compliance wasincomplete (for example, does not exhale fully) then the test may berejected and the patient instructed to repeat the test (branch 50).

When compliance is determined (branch 54), the sample is analyzed (step56) according to the predetermined detector unit protocol. Markersubstances, if present, may be quantified at each test interval if suchanalysis is included in the protocol. Each event may be reported (step58), either in real time through network communications or via periodicdownloads. To facilitate reporting and data logging, data regarding thequalitative (yes/no) values as well as the quantitative substance levelmay be stored within the detector in a memory unit such as a flash driveor disk. As is known in the art, such a storage medium may be used totransfer stored data to a health care provider device, thus providingcommunication to the patient device and health care provider device.Alternatively, as mentioned, the unit may upload the data live via acell connection or local network. Such upload may occur intermittentlyor immediately. Disk space may be freed up upon confirmation ofsuccessful upload, as needed. Reported events are analyzed (step 60),for example by being categorized as either negative or positive for thesubstance of interest based on a predetermined threshold for positivity,and therefore negative or positive for the smoking behavior. Thethreshold for positivity may be set at standard levels derived from thescientific literature or may be adjusted by the healthcare professionalto the specific needs of the patient. Such adjustments may occur in realtime based on data analysis and may include changes in the testing aswell as prompting protocols.

If the patient fails to respond (fails to blow into the unit) within acertain period of time after receiving the signal to respond (forexample, within 3 minutes although the time interval allowable fortesting may be set at any preferred value), the event is interpreted asa failure and flagged in the database. Data analysis can interpretfailed tests as being positive for smoking behavior or may omit thevalue entirely. The analysis tool is capable of variably dealing withsuch failed signals for testing. If considered positive for a smokingbehavior, a positive quantitative value may be assigned to that datapoint. Such a design prevents the patient from gaining a benefit(logging a negative data point) by ignoring a signal if they wereengaging in smoking at the time of the signal to test.

Programming necessary to implement the exemplary methodology illustratedin FIG. 3 may exist entirely within software or firmware resident inpatient device 10, divided between detector unit 12 and signaling unit16 as appropriate for the particular configuration of the device.Alternatively, such programming may at least in part reside in a serveror other source associated with base station 34, communicating withpatient devices 10 and 36 and/or detector unit 12 through communicationsnetwork 32.

Regardless of the exact embodiment of the invention as a single unit(combined and integrated) or multiple units, an advantage of the presentinvention is that it may be specifically configured for individualpatients so that the detector and signaling unit can be with the patientat all times. The patient is thus able to respond to a signalingnotification within the allotted and permitted time interval (i.e.,within about 2-10 minutes) at all times and may not use lack ofavailability as an excuse for noncompliance.

In one exemplary embodiment, the patent prompts are programmed to beintermittent and of varying intervals, so as not to be predictable. Thefrequency of prompting can vary throughout the day, and the pattern canbe unpredictable and non-repeating, thus preventing the patient frompredicting when they will be notified to blow into the detector or testsaliva. Alternatively, or additionally, the healthcare provider mayinitiate additional prompts through network 32 when in appropriatecircumstances. This unpredictability and variability prevents thepatient from modifying the timing of their smoking behavior in such amanner so as to avoid detection of the smoking behavior or to minimizethe quantitative result of the test. Further, the number of signalingevents per day can vary, for example on one day twenty signals may bedelivered, while on the next day only twelve are delivered. Variabilitycan be important, for example, if the signaling unit notified thepatient every hour on the hour, the smoker could smoke three cigarettesimmediately after the hour then avoid smoking for the remainder of thehour until prompted next. Presumably, during that hour-long interval ofno smoking, the substance detected in expired gas or saliva might returnto lower or even undetectable levels. To prevent the patient frompredicting when the notification will occur, the notification schedulewill be unpredictable and can be programmed in an infinite number ofpermutations based on frequency, number of notifications per day,max/min time between notifications, time allowed to respond, etc.Further, the pattern of notifications will not repeat itself onsubsequent days, further making the pattern unpredictable andundefeatable.

Patient devices 10, 36 according to embodiments of the invention may beprogrammed to be active during wake hours only or may include sleephours as well. In the former, the hours of operation are programmablebased on healthcare provider choice and patient need. One example wouldbe to have the unit active from 6 am to 12 midnight every day. Anotherexample would be to have the unit be normally active during the wakinghours with frequent notifications at unpredictable times, and thenrevert to an alternative schedule during sleep hours where only one ortwo signals occur at night. This would provide a modicum of aversion tosmoking at night by the patient in an attempt to defeat the system, yetwould not dramatically disrupt sleep patterns. Another alternative wouldbe to have the system active twenty-four hours per day, and night timefailed test events (no response by patient) be considered as sleepevents and not counted against the patient as positive for theundesirable behavior.

EXAMPLE

The following is one example of a practical application of oneembodiment of the invention. A patient is enrolled in a smokingcessation program and self-reports a certain amount of smoking behavior(number of cigarettes smoked per day) upon entry into the program(baseline smoking behavior). The patient completes the enrollmentprocess and initial counseling visit with a healthcare professional. Thepatient begins NRT and is provided with mobile patient device 10programmed to function between 6 am and 12 midnight each day. During theactive daily interval, the signaling unit prompts the patientapproximately twenty times each day to follow the provided instructionsfor how to perform exhalation testing with the detector unit. Thedetector unit may also provide displayed or audio instructions throughthe graphical user interface. The patient must comply within apredetermined time period (for example, within 3 minutes ofnotification) or else the event is considered a failure to respond. Inthe analysis of the data, this failure to respond can be treated as apositive smoking behavior event or can be ignored. In the example ofcarbon monoxide as the test substance, the level of CO (ppm) is recordedat each test instance. All data is logged and stored in the detector orsignaling unit (or uploaded real time or intermittently) untildownloaded to a software analysis program. Further, the user interfacemay prompt the patient to enter additional information about lifestyleevents that occur during the day (meals, activity, sex, alcoholconsumption, stress, travel, etc.) that can then be temporallycorrelated with smoking behavior as detected by the exhaled gas to drawconclusions about trigger events for smoking behavior. For example,after a test the detector unit may scroll through a number of potentialscenarios for selection by the patient (i.e., did you have a meal in thelast thirty minutes, did you have a drink in the last thirty minutes).If not uploaded automatically through a communications network, then atthe one-week visit, the healthcare provider downloads the data and usesa software program to analyze the data. Alternatively, the data wasuploaded in advance of the visit obviating the need for download. Aprint out is provided which shows the daily notification times and theassociated CO levels, as well as the missed or possibly faked responses.The analysis program is described further below, but there are severalsummary metrics which could be tracked to estimate the number ofcigarettes smoked and the timing of peak substance in the bloodstream.Correlations are made between program interventions versus trends insmoking behavior over time. Correlations are also made between recordedlifestyle events and smoking behavior to allow improved counseling anddrug therapy interventions. The printed analysis is provided to thepatient for positive/negative feedback regarding their progress andresponse to therapy. Each week, this process is repeated, progresstowards the goal of smoking cessation is tracked and medical therapy isadjusted according to the objective data in an optimized manner.

Analysis of the data can be performed in many different ways in variousalternative embodiments. Once the data is uploaded or downloaded, manydifferent metrics can be summarized and analyzed. Each day of use mayhave, for example, twenty test points for analysis. The timing andnumber of test points is variable and can be preprogrammed according tohealthcare professional recommendation and needs. Each test point willhave a yes/no, binary value, as well as a quantitative value. The yes/novalue may have a role in determining if the patient is smoking “at all”and, if any tests are “yes”, may provide some insight into how oftenduring the day the patient is smoking. The quantitative value for eachtest interval, if positive, may provide additional information about howoften the patient is smoking and trends towards abstinence. Also thesetrends can provide information about peaks of smoking during each dayand week. CO levels in expired gas, for example, peak immediately aftersmoking a cigarette or series of cigarettes, and then gradually declineover time. A time vs. CO level could be plotted and a predictivealgorithm created to estimate the number of cigarettes and time ofsmoking per day for each patient. A time vs. CO level plot for each testperiod (day, week, month, year) provides significant information to thehealthcare provider regarding patient progress in a longer term programand allows alteration of therapy in an objective manner. Further, on thetime vs. CO plot, data regarding administration of medication, changesin medication regimens over time, counseling interventions, etc. can beannotated and used to track effect of each intervention and dose change.Such data analysis functionality may be incorporated into patientdevices 10, 36, or may reside in healthcare provider base station 34.

Another software analysis feature involves an interactive program thatthe patient engages within the interval between cessation program visits(for example, between biweekly program visits). Such a patient-interfacecould be used by persons who independently utilize this cessation systemoutside of a smoking cessation program. While the devices would besimilar to the previously disclosed detector and signaling units, suchan embodiment may include means by which the patient can upload the dataon a regular basis to a local or remote source (or both) and followtheir data on a regular basis for trends and feedback. As the data isuploaded and analyzed, the data is added to previously uploaded data andcan be viewed by the patient and healthcare provider and otherauthorized persons. The data can be displayed for any party in the samemanner as it is displayed for the healthcare professional.Alternatively, unique, patient-friendly interactive displays can beprovided for the patient so that they can track and observe theirsmoking behavior in a number of ways, including total number of days inthe program, baseline smoking behavior compared to current smokingbehavior, number of cigarettes avoided in last period of time, number ofhours, days, months, and years of lifetime saved, time to goal ofsmoking cessation, daily results, weekly results, progress towards goaldisplayed numerically or graphically. Other metrics can also be trackedand correlated with smoking behavior results, such a blood pressure,heart rate, body weight, quality of life testing, stress levelquestionnaire results, and others. If viewed simultaneously by thequalified health care professional, prompts can be provided to thepatient that are positive reinforcement about good behavior andimprovements, alterations that may be made to drug therapy, observationsabout lifestyle events that may be precipitating smoking behavior, etc.Additionally, the patient can observe within the analysis program whichlifestyle events may be impacting daily smoking behavior. Avoidance ofthese situations can then ensue.

In such a patient-centric interactive program, a series of questionscould be levied each day (or more or less frequently) to the patient,which could be standardized or could be prompted by certain changes(improvement or worsening) in smoking behavior. For example, a patientmay be asked at the end of each day to log in the analysis program thenumber of cigarettes smoked, blood pressure measurement, heart rate,quality of life scale questions, significant life event, etc. Results ofthese queries can be tracked overtime with the smoking behaviorobjective readings from the CO monitoring data. Such linkage of patientvolunteered data as well as objective data and therapeutic interventiondata are helpful for the patient and healthcare professional to tailortherapy optimally.

While exemplary embodiments of the invention are described above with afocus on smoking behaviors, examples of which include but are notlimited to smoking of tobacco via cigarettes, pipes, cigars, and waterpipes, and smoking of illegal products such as marijuana, cocaine,heroin, and alcohol related behaviors, it will be immediately apparentto those skilled in the art that the teachings of the present inventionare equally applicable to any number of other undesired behaviors forwhich markers are present in the breath and/or saliva. Such otherexamples include: oral placement of certain substances, with specificexamples including but not limited to placing chewing tobacco and snuffin the oral cavity, transdermal absorption of certain substances, withspecific examples including but not limited to application on the skinof certain creams, ointments, gels, patches or other products thatcontain drugs of abuse, such as narcotics, LSD, GHB, Rohypnol, ketamine,methamphetamine, PCP/phencyclidine, anabolic steroids, and secreted orexhaled metabolites of said substances, and nasal sniffing of drugs orsubstances of abuse, which includes but is not limited to sniffingcocaine. In general, the basic configuration of patient devices 10, 36,as well as the prompting, self-testing, data logging, feedback and othersteps and methods as disclosed herein will be similar as between thedifferent behaviors that are being addressed. However, detector unit 12may differ somewhat in design only to account for different markersubstances that are required for testing or different testingmethodology necessitated by the different markers associated withparticular undesired behaviors.

It will also be appreciated by persons of ordinary skill in the art thata patient participating in a formal cessation program may take advantageof the assistive devices, methods and systems disclosed herein asadjuncts to the cessation program. However, in alternative embodiments,it will be equally appreciated that the patient may be independentlyself-motivated and thus beneficially utilize the assistive devices,methods and systems for quitting the undesired behavior unilaterally,outside of a formal cessation program.

In further exemplary embodiments of the present invention, devices,systems and methods disclosed herein may be readily adapted to datacollection and in particular to collection of reliable and verifiabledata for studies related to undesired behaviors for which the presentinvention is well suited to test. Such studies may be accomplished withvirtually no modification to the underlying device or methods exceptthat where treatment was not included there would not necessarily be aneed for updating of the test protocol or treatment protocol based onuser inputs.

Exemplary embodiments have been disclosed above and illustrated in theaccompanying drawings. It will be understood by those skilled in the artthat various changes, omissions and additions may be made to that whichis specifically disclosed herein without departing from the spirit andscope of the present invention.

What is claimed is:
 1. A system for facilitating cessation of undesiredbehavior in a patient, comprising: a module containing at leastinstructions comprising a predetermined test protocol, the test protocolincluding a number and timing of patient testing prompts; a patientdevice (PD) configured and dimensioned to be carried by the patient, thepatient device comprising; a PD user interface, a test elementconfigured to receive a biological input from the patient and outputinformation representative of the content of the biological input, a PDstorage module containing at least instructions for prompting thepatient through the PD user interface to provide a biological input tothe test element at selected intervals corresponding to thepredetermined test protocol, the PD storage module further containinginstructions for receiving from the patient through the PD userinterface a non-biological lifestyle input relating to the patient,wherein the PD is configured for determining the completeness of thebiological input, and providing additional patient prompts based on saidcompleteness determination; and a PD execution module communicating withthe PD user interface, the test element and the storage module, the PDexecution module configured to execute instructions contained in said PDstorage module; and a health care provider device (HCPD) configured tobe accessed by a health care provider, comprising: an HCPD userinterface, a HCPD storage module containing at least instructions fordisplaying and manipulating information representative of the content ofthe biological input, the HCPD storage module further containinginstructions for associating the non-biological lifestyle input with thecontent of the biological input that is closest in time to thenon-biological lifestyle input, wherein the HCPD is further configuredfor evaluating the predetermined test protocol including the number andtiming of patient test prompts based on at least one of user input andsaid information representative of the content of the biological input,where an evaluation comprises categorizing the biological input andnon-biological lifestyle input as either negative or positive forsmoking behavior relative to a predetermined threshold, and wherein theHCPD is further configured for altering or maintaining the predeterminedtest protocol based on said evaluation of a negative or positivedetermination for smoking behavior; and an HCRD execution modulecommunicating with the HCPD user interface and HCPD storage module, theexecution module configured to execute instructions contained in saidHCPD storage module, wherein said PD and HCPD are configured forcommunication there between.
 2. The system of claim 1, wherein one ofthe PD or HCPD storage modules contains instructions for generating amachine readable data set based on said test element output information,and for associating said data set with a specific patient biologicalinput.
 3. The system of claim 2, wherein one of the PD or HCPD storagemodule contains instructions for causing the patient device to promptthe patient to input requested information to said patient devicethrough the PD user input and for associating the requested informationwith a data set associated with a specific patient biological input. 4.The system of claim 1, wherein the test element comprises a detectorconfigured to detect substances in exhaled breath.
 5. The system ofclaim 1, wherein the test element comprises a detector configured todetect substances in saliva.
 6. The system of claim 1, wherein thepatient device and healthcare provider device are configured forcommunication through a network.
 7. The system of claim 6, wherein thenetwork is a telephone network.
 8. The system of claim 6, wherein thenetwork is a computer network.
 9. The system of claim 6, wherein thenetwork is the Internet.
 10. The system of claim 1, wherein the patientdevice and health care provider device are configured for communicationthrough a transferrable storage medium.
 11. The system of claim 1,wherein the patient device and health care provider device areconfigured for communication through a direct wired connection.
 12. Thesystem of claim 1, further comprising plural said patient devicesconfigured to communicate with at least one said health care providerdevice.
 13. The system of claim 1, wherein the PD storage module furtherincludes instructions for delaying said determining the completeness ofthe biological input for a set period in response to a patient inputthrough the PD user interface.
 14. The system of claim 1, wherein: thepatient device is contained within a housing; the patient device furthercomprises an identification device for acquiring patient identifyinginformation correlated to the biological input; and said identificationdevice communicating with said storage module and execution module forassociating the acquired identifying information with the correlatedbiological input and storing said associated identifying information.15. The system of claim 1, wherein the PD storage module furtherincludes instructions for receiving unprompted patient input through thePD user interface and for associating said unprompted input with thebiological input based on a predetermined algorithm.
 16. The system ofclaim 1, wherein said patient device is contained within a housing. 17.The system of claim 1, wherein said patient device comprises at leasttwo housings, with the test element disposed in one housing and the PDuser interface disposed in a separate housing, and wherein said testelement and PD user interface are configured for wireless communicationthere between.
 18. The system of claim 1, wherein said test element isconfigured for detecting one or more substances associated with smokingtobacco products.
 19. The system of claim 1, wherein said test elementis configured for detecting one or more substances associated withsmoking of illegal drugs.
 20. The system of claim 1, wherein said testelement is configured for detecting alcohol.
 21. The system of claim 1,wherein the test element is configured for detecting substancesassociated with oral ingestion or transdermal absorption of specifiedcompounds.
 22. The system of claim 21, wherein said specified compoundsinclude one of molecules related to benzodiazepines, narcotics, LSD,GHB, Rohypnol, ketamine, methamphetamine, PCP/phencyclidine, anabolicsteroids, and secreted or exhaled metabolites of said substances. 23.The system of claim 1, wherein the test element is configured fordetecting one or more substances associated with oral placement ofproducts.
 24. The system of claim 1, wherein the test element isconfigured for detecting one or more substances associated with nasalsniffing of substances of abuse.
 25. The system of claim 1, wherein themodule containing the instructions comprising the predetermined testprotocol is disposed within the PD storage module.
 26. The system ofclaim 1, wherein the module containing the instructions comprising thepredetermined test protocol is disposed within the HCPD storage module.27. The system of claim 1, wherein the predetermined test protocolfurther includes prompting the patient to input information regardingpatient life events associated with select test protocol events.
 28. Anapparatus for use in connection with facilitating cessation of undesiredbehavior in a patient, comprising: at least one housing configured anddimensioned to be carried by the patient; a user interface disposed insaid at least one housing; a test element disposed in said at least onehousing, the test element being configured to receive a biological inputfrom the patient and output information representative of the content ofthe biological input, a storage module containing instructionscomprising: a) executing a predetermined test protocol including anumber and timing of patient test prompts, said protocol furthercomprising: prompting the patient through the user interface to providea biological input to the test element at selected intervalscorresponding to the number and timing of patient test prompts,determining the completeness of a biological input, providing additionalpatient biological input prompts based on said completenessdetermination, prompting the patient to input requested informationthrough said user interface, and receiving from the patient through theuser interface a non-biological lifestyle input relating to the patient,b) generating user readable indicator based on said test element outputand displaying said output on the user interface, c) associating theuser readable indicator with a specific biological input, d) associatingthe requested information with a specific user readable indicatorassociated with a specific patient biological input, e) associating thenon-biological lifestyle input with the specific biological input thatis closest in time to the non-biological lifestyle input, f) storingtest result information including the user readable indicator andassociated requested information in said storage module, and g)evaluating the predetermined test protocol by categorizing thebiological input and non-biological lifestyle input with either anegative or positive for smoking behavior relative to a predeterminedthreshold; and an execution module communicating with the userinterface, the test element and the storage module, the execution moduleconfigured to execute said instructions, wherein said apparatus isconfigured to communicate through a network for transfer of said testresult information and to receive instructions for altering thepredetermined test protocol based on a remote evaluation of said testresult information.
 29. The apparatus of claim 28, wherein the storagemodule further includes instructions for delaying said determining thecompleteness of biological input for a set period in response to apatient input through the user interface.
 30. The apparatus of claim 29,further comprising an identification device for acquiring patientidentifying information correlated to a biological input, saididentification device communicating with said storage module andexecution module for associating the acquired identifying informationwith the correlated biological input and storing said associatedidentifying information.
 31. The apparatus of claim 30, wherein saidapparatus comprises a single housing.
 32. The apparatus of claim 28,wherein said apparatus comprises two housings with the test elementdisposed in a first housing and said user interface, storage module andexecution module disposed in a second housing, said test element andexecution module being configured for wireless communication therebetween.
 33. An apparatus for use in connection with facilitatingcessation of undesired behavior in a patient, comprising: a housingconfigured and dimensioned to be carried by the patient; a userinterface disposed in said housing, the user interface configured toprompt the patient; a test element disposed in said housing, the testelement being configured to receive a biological input from the patientand output information representative of the content of the biologicalinput; a patient identification module disposed in said housingconfigured to recognize a unique characteristic of the patient; at leastone storage module disposed in said housing containing instructionscomprising: a) instructions for executing a predetermined test protocol,the test protocol including a pre-determined number and timing ofpatient test prompts, the instructions including, prompting the patientthrough the user interface to provide a biological input to the testelement at selected intervals in accordance with the test protocol,determining the completeness of a biological input, providing additionalpatient biological input prompts based on said completenessdetermination, prompting the patient to input requested informationthrough said user interface, and receiving from the patient through theuser interface a non-biological lifestyle input relating to the patient,b) instructions for generating user readable indicator based on saidtest element output and displaying said output on the user interface, c)instructions for associating the test element output with a specificbiological input, d) instructions for associating any requestedinformation with a specific test element output associated with aspecific patient biological input, e) instructions for associating thenon-biological lifestyle input with the specific biological input thatis closest in time to the non-biological lifestyle input, f)instructions for initiating the patient identification module correlatedto said prompting and re-prompting upon determination of an unrecognizedpatient characteristic, and g) instructions for evaluating thepredetermined test protocol by categorizing the biological input andnon-biological lifestyle input with either a negative or positive forsmoking behavior relative to a predetermined threshold; and an executionmodule communicating with the user interface, the test element, thestorage module and the patient identification module, the executionmodule configured to execute said instructions, wherein said apparatusis configured to communicate through a network.
 34. The apparatus ofclaim 33, wherein the storage module further contains instructionscomprising: g) evaluating the predetermined test protocol based on saidtest result information; and h) altering or maintaining thepredetermined test protocol based on said evaluation, said alteringincluding changing at least one of the predetermined number or timing ofpatient test prompts.
 35. The apparatus of claim 33, wherein the storagemodule further contains instructions for altering the predetermined testprotocol including changing at least one of the predetermined number ortiming of patient test prompts in response to an altering instructionreceived through the communication network.
 36. The apparatus of claim33, wherein said apparatus is configured to receive the predeterminedtest protocol through said network communication.
 37. The apparatus ofclaim 33, wherein the instructions prompting the patient for requestedinformation includes instructions prompting the patient to inputinformation through the user interface identifying patient activity atthe time of the test prompt.
 38. An apparatus for use in connection withfacilitating cessation of undesired behavior in a patient, comprising: ahousing configured and dimensioned to be carried by the patient; agraphical user interface disposed in said housing, said interfaceconfigured to prompt the patient and receive informational inputs by thepatient; a test element disposed in said housing, the test element beingconfigured to receive a biological input from the patient and outputinformation representative of the content of the biological input, astorage module within said housing containing instructions comprisinginstructions for: a) executing a predetermined test protocol including anumber and timing of patient test prompts, said protocol furthercomprising prompting the patient through the user interface to provide abiological input to the test element at selected intervals correspondingto the number and timing of patient test prompts, determining thecompleteness of a biological input, providing additional patientbiological input prompts based on said completeness determination, andreceiving from the patient through the user interface a non-biologicallifestyle input relating to the patient, b) generating user readableindicator based on said test element output and displaying said outputon the graphical user interface, c) associating the test element outputwith a specific biological input, d) associating the non-biologicallifestyle input with the specific biological input that is closest intime to the non-biological lifestyle input, e) transferring said testresult information including the test element output associated with aspecific biological input to a network or storage device; f) receivinginstructions for altering the predetermined test protocol based on aremote evaluation of said test result information, and g) evaluating thepredetermined test protocol by categorizing the biological input andnon-biological lifestyle input with either a negative or positive forsmoking behavior relative to a predetermined threshold, and an executionmodule within said housing communicating with the graphical userinterface, the test element and the storage module, the execution moduleconfigured to execute said instructions.
 39. The apparatus of claim 38,wherein the storage module further includes instructions for delayingsaid determining the completeness of biological input for a set periodin response to an patient input through the user interface.
 40. Theapparatus of claim 38, further comprising an identification devicedisposed in said housing for acquiring patient identifying informationcorrelated to a biological input, said identification devicecommunicating with said storage module and execution module forassociating the acquired identifying information with the correlatedbiological input.
 41. The apparatus of claim 38, wherein said apparatusis adapted for use in a smoking cessation treatment program and saidtest element is configured to detect the presence of a marker indicatingsmoking behavior.
 42. The apparatus of claim 38, wherein said apparatusis configured to communicate with a remote station through at least oneof a wireless or cellular network, removable storage device or wiredconnection for said transfer of test result information and said receiptof instructions.
 43. The apparatus of claim 38, wherein saidinstructions further comprise instructions for associating informationalinputs through the graphical user interface with specific patientbiological inputs, and transferring said associated informational inputswith said test result information.